Trial record 5 of 5551 for:    Open Studies | "Digestive System Diseases"

Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Royal Marsden NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01037049
First received: December 18, 2009
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks.

Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.


Condition
Adenocarcinoma of the Rectum
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI]. [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI]. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Difference in proportion of patients in each arm undergoing sphincter saving surgery. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • An analysis will also be undertaken using multivariate and linear regression analysis to evaluate the association of ypT and ypN stage as a potential independent predictors of SUV (max) baseline and after radiotherapy (pre-surgery) in the two arms. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Local and distant recurrence rates. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Radiotherapy related toxicity rates. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 218
Study Start Date: October 2009
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy
Group 2
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Group 3

Patients who do not have surgery at their allocated times (6 or 12 weeks) because:

Disease progressed. No further treatment; Disease progressed/stable. Further treatment; Patient refused surgery; Metastatic disease. Palliative treatment; Good Response/In Deferral of Surgery Trial; Patient died during treatment; Other.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have adenocarnoma of the rectum.

Criteria

Inclusion Criteria:

  • Aged > 18
  • Informed written consent
  • Histological confirmation of adenocarcinoma of rectum
  • Undergoing pre-operative radiotherapy/ chemotherapy
  • Completion of pre-operative treatment

Exclusion Criteria:

  • Aged < 18
  • Absence of pre-operative RT/CT
  • Medical/ psychiatric conditions that compromise the patients ability to give informed consent
  • Contra-indications to MRI, i.e. hip prothesis, cardiac pacemaker
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037049

Contacts
Contact: Lisa Scerri lisa.scerri@rmh.nhs.uk
Contact: Gina Brown 0208 661 3964 gina.brown@rmh.nhs.uk

Locations
Brazil
Hospital Alemão Oswaldo Cruz Recruiting
Sao Paulo, Brazil, 01323-903
Principal Investigator: Angelita Habr-Gama         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Principal Investigator: Tamim Niazi         
Cyprus
Bank of Cyprus Oncology Centre Recruiting
Nicosia, Cyprus
Principal Investigator: Vasilis Vasiliou         
United Kingdom
Hinchingbrooke Hospital Recruiting
Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
Principal Investigator: David Mitchell         
County Durham and Darlington NHS Trust (University Hospital of North Durham) Recruiting
Durham, County Durham, United Kingdom, DH1 5TW
Principal Investigator: Jeremy Cindall         
North Tees and Hartlepool NHS Trust (University Hospital of North Tees) Recruiting
Stockton-on-Tees, County Durham, United Kingdom, TS24 9AH
Principal Investigator: David Wilson         
Dorset County Hospital NHS Foundation Trust Recruiting
Dorchester, Dorset, United Kingdom, DT1 2JY
Principal Investigator: Maxine Flubacher         
Poole Hospital NHS Foundation Trust Recruiting
Poole, Dorset, United Kingdom, BH15 2JB
Principal Investigator: Andrew Clarke         
Essex County Hospital Recruiting
Colchester, Essex, United Kingdom, CO3 3NB
Principal Investigator: Bruce Sizer         
Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital) Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Principal Investigator: Suhail Baluchi         
Medway NHS Foundation Trust Recruiting
Gillingham, Kent, United Kingdom, ME7 5NY
Principal Investigator: William Garrett         
North West London Hospitals NHS Trust (Northwick Park Hospital) Recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
Principal Investigator: Ian Jenkins         
James Paget University Hospitals NHS Foundation Trust Recruiting
Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
Principal Investigator: Kamal Aryal         
Epsom and St Helier's Hospitals NHS Trust Recruiting
Carshalton, Surrey, United Kingdom, SM5 1AA
Contact: Paul Toomey       paul.toomey@esth.nhs.uk   
Principal Investigator: Paul Toomey         
St Richard's Hospital Recruiting
Chichester, West Sussex, United Kingdom, PO19 6SE
Principal Investigator: Neil Cripps         
Mid Yorkshire Hospitals NHS Trust (Pinderfields Hospital) Recruiting
Wakefield, West Yorkshire, United Kingdom, WF1 4DG
Principal Investigator: Cathy Parchment-Smith         
Royal United Hospital NHS Trust Recruiting
Bath, United Kingdom, BA1 3NG
Contact: Emma De Winton       emma.dewinton@nhs.net   
Principal Investigator: Emma De Winton         
Sandwell and West Birmingham Hospitals NHS Trust Recruiting
Birmingham, United Kingdom, B18 7QH
Principal Investigator: Vijay Thumbe         
Croydon University Hospital Recruiting
Croydon, United Kingdom, CR7 7YE
Contact: Ian Swift         
Principal Investigator: Ian Swift         
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Principal Investigator: Amen Sibtain         
St George's Healthcare NHS Trust Recruiting
London, United Kingdom, SW17 0QT
Principal Investigator: Fiona Lofts         
Pennine Acute Hospitals NHS Trust Recruiting
Manchester, United Kingdom, M8 5RB
Principal Investigator: Salim Kurrimboccus         
Royal Marsden NHS Trust Recruiting
Sutton, United Kingdom, SM2 5PT
Principal Investigator: Diana Tait         
Principal Investigator: Gina Brown         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Diana Tait Royal Marsden NHS Foundation Trust
Principal Investigator: Gina Brown Royal Marsden Hospitals NHS Foundation Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01037049     History of Changes
Other Study ID Numbers: CCR3227
Study First Received: December 18, 2009
Last Updated: November 21, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
Rectal Cancer
6vs12
6 vs 12
Cancer
CRM
Circumferential Resection Margin
Quality of Life
MRI
Radiology
Abdominoperineal Excision
Anterior Resection
Surgery
Pathology
Radiotherapy

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Adenocarcinoma
Neoplasms
Carcinoma
Adenocarcinoma, Mucinous
Colorectal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases
Rectal Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Colonic Diseases

ClinicalTrials.gov processed this record on July 24, 2014